The United States Biological Proteinase-3, Human, BioAssay ELISA Kit is intended for the detection and semi-quantitative determination of antibodies to PR-3 in human serum. The assay is to be used to detect antibodies in a single serum specimen. Proteinase-3 is a lysosomal enzyme that can be found in human neutrophils. There are two subsets of autoantibodies to sample neutrophils, c- ANCA and p-ANCA. The first subtype, c-ANCA, shows cytoplasmic staining by IFA and is diagnostic for Wegener's granulomatosis. The major antigen responsible for the c-ANCA staining is Proteinase-3. The second subtype, p- ANCA, shows perinuclear staining by IFA. The major antigen responsible for the p-ANCA response has been shown to be myeloperoxidase. The ANCA staining patterns are obtained using ethanol-fixed sample neutrophils. Anti- PR-3 autoantibodies have been associated with Wegener's granulomatosis but less often with microscopic polyangiitis. Other antigen specificity's (CAP 57) can be responsible for the c-ANCA pattern. These antigens are generally not diagnostic for PR-3 associated vaculitus diseases. Kit Components:Each kit contains the following components in sufficient quantities to perform the number of tests indicated on the package label.1. Microtiter Plate: 1x96 wells2. Sample Diluent: 1x30ml3. Positive Control, High: 1x400ul4. Calibrator: 1x400ul5. Negative Control: 1x400ul6. Positive Control, Low: 1x400ul7. IgG, IgA, IgM (HRP) Goat x human: 1x15ml8. Wash Buffer, 20X: 1x50ml9. Tetramethylbenzidine (TMB): 1x15ml10. Stop Solution: 1x15ml Storage and Stability:Store all components at 4°C. Stable for 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.
